Manager
Glenmark Pharmaceuticals
- Location
- Navi Mumbai, Maharashtra, India
- Job type
- Full-time
Required skills
- clinical trials
- cross-functional
- database
About the role
Glenmark Pharmaceuticals
Website:
glenmarkpharma.com
Job details:
Job Description
- Lead or participate in cross-functional safety review teams for productsin clinical development: Active participation inmonitoring safety of products in clinical development; lead discussions incross-functional review meetings on safety issues for products in clinicaldevelopment. Collaborating with other members of the drug development team,including pharmacologists, toxicologists, and statisticians, to ensure thatsafety issues are adequately addressed. Be responsible for safety surveillanceactivities for this product including medical review of individual safety casesdirectly in the safety database and signal detection activities (ongoing reviewof safety data). Escalate and present safety issues at company safetygovernance bodies. Be a member of study teams and work in a collaborative andproactive way in a matrix environment. Participate in DMC (Data MonitoringCommittee) meetings or other safety-related interactions with outsidecollaborators, and in internal safety task forces. Be involved in processoptimization initiatives and, where needed, set up new activities.
- Review and provide input into safety sections ofstudy related documents: Participatingin the design and conduct of clinical trials to ensure that safety and efficacydata are collected and analyzed appropriately. Provide scientific and medical input from a safety perspectivewhile preparation of study documents including study protocols (includingPASS), IB, ICF, CRFs, SAE forms, clinical study reports etc.
- Author/review/approve safety reports of products in clinicaldevelopment/marketed products: Author/review/approveall types of safety reports including DSURs, PADERs, PSURs, PBRERs, Addendum toClinical Overview, other Benefit-Risk/Safety Assessment reports
- Perform signal detection/evaluation and prepare Health Hazard Assessmentreports: Evaluate clinical safety data to identify signaltrends or any potential safety issues. Evaluate information/data generated fromthe safety database, literature sources and data sources outside the ownershipof PV (clinical trials, observational studies, preclinical data, epidemiologyetc.) as well as external pre-evaluated information such as regulatoryauthority requests/data etc for identification of signals. Present analysedsignals to the Glenmark Signal Management Team (SMT) and where applicable, toHuman Safety Group (HSG) for assigned products and support labelling relatedactivities. Evaluate the potential clinical safety ramifications of productquality issues and contribute to recommendations for actions;author/review/approve Health Hazard Assessment Reports
- Risk Management Plans and Risk MinimizationMeasures: Participating in thedevelopment of risk management plans, which outline strategies for minimizingthe risk of adverse events associated with developmental or marketed drugs.
- Respond to regulatory authority/healthcare professionals queries forassigned products: Generate and lead preparation of high-qualityresponses to regulatory authority queries within stipulated timelines
- Support during audits, inspection and CAPA management: Promptly fulfil document requests arising from audits and inspections.Participate in audit and inspection interviews as needed. Contribute to thedevelopment and fulfilment of applicable CAPAs.
- Support assessment and implementation of regulatoryintelligence: Completeimpact assessments of regulatory intelligence including development andexecution of action plans, especially when it relates to local regulations.Staying up-to-date with the latest developments in drug safety, including newregulations and guidelines, to ensure that safety evaluations are conducted inaccordance with the latest standards.
- Provide technical guidance in the development and maintenance of proceduraldocumentation: Contribute to the development and maintenance ofStandard Operating. Procedures, Working Guidelines, Polices and training of PVand non PV staff to meet global regulations guidelines and organizationalstandards
- Support organisational initiatives in driving global operationalexcellence in Pharmacovigilance: Liaise andcollaborate with various GPV and non-GPV functions, Glenmark local affiliateand external business partners to ensure alignment. Participate and/or leaddiscussions in Governance meetings. Lead or contribute towards processimprovement initiatives, pro-actively identify potential process improvements. Participate/leadin GPV branding activities.
- Support GPV leadership including QPPVs in oversight of KPIs: Perform delegated tasks and ensure relevant KPIs are generated forsenior GPV management including the QPPV for oversight.
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